Key Facts

Remote From:

Freelance

Senior (5-10 years)

Hard Skills

Drug Development Regulatory Compliance Regulatory Compliance Pharmaceutical Formulation Regulatory Compliance Business Negotiation

Other Skills

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Quality Control
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Social Skills
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Logical Reasoning
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Communication

Roles & Responsibilities

University degree in Pharmacy or a natural science field
3+ years of CMC regulatory experience in pharmaceutical development (pharma company or CRO)
Experience preparing regulatory submission materials (CMC/CTD/MF/FMA) and regulatory dossiers
Business-level English for communication (speaking and writing); TOEIC around 700

Requirements:

Under guidance of the project leader, develop CMC regulatory strategies for drug development stages and for manufacturing/marketing authorization filings and post-approval change management; liaise with clients
Collaborate with clients to prepare CMC-related regulatory submissions and consultation materials, including analysis/evaluation of existing CMC data and planning for Japan clinical development
Prepare manufacturing/marketing authorization submission packages (new applications, variation filings, minor change notifications), PMDA consultation materials, and manage regulatory inquiries; support post-submission inquiries to obtain MA
Support domestic CMC regulatory tasks such as Master File (MF) and Foreign Manufacturer Accreditation (FMA), GMP compliance assessments, Cartagena Act filings, and internal change-management within regulatory affairs

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

External Job Description

職務内容：

プロジェクトリーダーの指示のもと、新薬開発段階での開発戦略及びCMC薬事戦略策定から製造販売承認申請及び承認取得後の製品の変更管理に関わるCMC薬事業務全般。また、クライントと協議、交渉を行う。
パレクセルの業務遂行手順を順守する。
クライアントに提出する成果物に、新たに習得した知識を効果的に反映させる。

業務内容

プロジェクトにアサインされた後、クライアントと協同して、下記のコンサルテーションやCMC関連の薬事申請資料を作成サポートします。